Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Exploratory Study to Evaluate the Efficacy and Safety of HAD-B1 for Dose-Finding in EGFR Mutation Positive and Locally Advanced or Metastatic NSCLC Subjects Who Need Afatinib Therapy

Ko, Eun-Ju; Kwag, Eun-Bin; Park, Ji Hye; Park, So‐Jung; Son, Ji Woong; Yoon, Seong-Hun; Shin, Seong-Hun; Yoo, Hwa‐Seung

doi:10.1177/15347354211037917

Cited by 3 publications

(1 citation statement)

References 27 publications

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“… 30 Interestingly, the concentration of ginsenoside F5 in the plasma of this patient was higher than those with skin rash, which is a compound found in Panax ginseng. 31 Therefore, it is possible that the use of ginseng may have had a beneficial effect on the erlotinib-induced skin rash. These uncontrolled drug and food intakes may have interfered with the investigation of the plasma metabolome.…”

Section: Discussionmentioning

confidence: 99%

Comparison of Plasma Metabolites From Patients With Non-Small Cell Lung Cancer by Erlotinib Treatment and Skin Rash

Lee,

Myong,

Kwag

et al. 2023

Integr Cancer Ther

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Erlotinib is a necessary anticancer treatment for non-small cell lung cancer (NSCLC) patients yet it causes severe side effects such as skin rash. In this study, researchers compared the untargeted compound profiles before and after erlotinib administration to observe changes in blood metabolites in NSCLC patients. The levels of 1005 substances changed after taking erlotinib. The levels of 306 and 699 metabolites were found to have increased and decreased, respectively. We found 5539 substances with peak area differences based on the presence of skin rash. Carbohydrate, amino acid, and vitamin metabolic pathways were altered in response to the onset of erlotinib-induced skin rash. Finally, this study proposed using plasma metabolites to identify biomarker(s) induced by erlotinib, as well as target molecule(s), for the treatment of dermatological toxic effects.

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Section: Discussionmentioning

confidence: 99%

Comparison of Plasma Metabolites From Patients With Non-Small Cell Lung Cancer by Erlotinib Treatment and Skin Rash

Lee,

Myong,

Kwag

et al. 2023

Integr Cancer Ther

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Chemical Constituents and Pharmacological Properties of Frankincense: Implications for Anticancer Therapy

Wu,

Xiong,

Dong

et al. 2024

Chin. J. Integr. Med.

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A Randomized, Multi-Center, Open Label Study to Compare the Safety and Efficacy between Afatinib Monotherapy and Combination Therapy with HAD-B1 for the Locally Advanced or Metastatic NSCLC Patients with EGFR Mutations

Kwag,

Kim,

Shin

et al. 2024

Integr Cancer Ther

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Background: Lung cancer, especially non-small cell lung cancer (NSCLC), poses a significant health challenge globally due to its high mortality. Afatinib, a second-generation epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI), has shown superior efficacy over traditional chemotherapy in NSCLC treatment. However, issues like secondary resistance and adverse effects call for alternative therapies. HAD-B1, comprising 4 herbal medicines, has shown promise in lung cancer treatment in both preclinical and clinical settings. This study assesses the combination of HAD-B1 and Afatinib in advanced NSCLC patients to potentially improve outcomes by addressing the limitations of current EGFR-TKI therapies. Method: A randomized, open-label trial evaluated the efficacy and safety of HAD-B1 with Afatinib in 90 EGFR-mutation-positive NSCLC patients. Participants were divided into treatment and control groups, receiving Afatinib with or without HAD-B1. The study focused on the initial dose maintenance rate and disease control rate (DCR) of Afatinib, alongside secondary outcomes like survival rates and quality of life, under continuous safety monitoring. Results: Among the 90 participants, no significant difference was found in initial dose maintenance (60.98% in the treatment group vs 52.50% in the control, P = .4414) or DCR (80.49% vs 90.00%, P = .2283). Secondary outcomes like PFS, TTP, and OS showed no notable differences. However, physical functioning significantly improved in the treatment group ( P = .0475, PPS group). The control group experienced higher rates of adverse events of special interest and adverse drug reactions ( P = .01), suggesting HAD-B1 with Afatinib might enhance physical function without increasing adverse effects. Conclusion: Combining HAD-B1 with Afatinib potentially improves quality of life and reduces adverse events in advanced NSCLC patients. Further research is necessary to confirm the long-term benefits of this combination therapy, aiming to advance NSCLC treatment outcomes. Trial registration: Clinical Research Information Service (CRIS) of the Republic of Korea, https://cris.nih.go.kr/ (ID: KCT0005414).

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Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Exploratory Study to Evaluate the Efficacy and Safety of HAD-B1 for Dose-Finding in EGFR Mutation Positive and Locally Advanced or Metastatic NSCLC Subjects Who Need Afatinib Therapy

Cited by 3 publications

References 27 publications

Comparison of Plasma Metabolites From Patients With Non-Small Cell Lung Cancer by Erlotinib Treatment and Skin Rash

Comparison of Plasma Metabolites From Patients With Non-Small Cell Lung Cancer by Erlotinib Treatment and Skin Rash

Chemical Constituents and Pharmacological Properties of Frankincense: Implications for Anticancer Therapy

A Randomized, Multi-Center, Open Label Study to Compare the Safety and Efficacy between Afatinib Monotherapy and Combination Therapy with HAD-B1 for the Locally Advanced or Metastatic NSCLC Patients with EGFR Mutations

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